2024-15009. Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Table 1—Estimated Annual Third-Party Disclosure Burden ¹

Recommended disclosure activity; guidance section	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
Clearly identify both the specific misinformation that the firm is addressing and a specific internet-based, independent third-party communication in which that misinformation appears; Section IV.A. Q3	958	50	47,900	0.4 (24 minutes)	19,160
A mechanism for obtaining a copy of the current FDA-required labeling (including FDA-approved patient labeling, if any); Section IV.A. Q5	958	50	47,900	0.1 (6 minutes)	4,790
The date the firm's tailored responsive communication is posted (if a date is not automatically generated); Section IV.A. Q5	958	50	47,900	0.05 (3 minutes)	2,395
A disclosure that the tailored responsive communication is being shared by the medical product firm or that the person addressing the misinformation is affiliated with the firm and is authorized to provide information on behalf of the firm about the medical product; Section IV.A. Q5	958	50	47,900	0.1 (6 minutes)	4,790
In the case of a tailored responsive communication that addresses misinformation about an unapproved use of the firm's approved/cleared medical product, a disclosure identifying the unapproved use and noting that the unapproved use of the medical product has not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use has not been established; Section IV.A. Q5	958	5	4,790	0.1 (6 minutes)	479
Total			196,390		31,614
1  There are no capital costs or operating and maintenance costs associated with this collection of information.